BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 146601 · Received January 30, 1998

    Report

    Report Number
    6000072-1998-00001
    Event Type
    Injury
    Date Received
    January 30, 1998
    Date of Event
    April 1, 1997
    Report Date
    January 5, 1998
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PROCEDURE PERFORMED ON THE PT IN 4/97 DID NOT WORK, THE DEVICE WAS A FAILURE. ONE MONTH LATER THE PT HAD TO HAVE ANOTHER PROCEDURE DONE. THE MFR HAS NOT REC'D ANY OTHER NOTIFICATION OF AN INCIDENT AGAINST THIS LOT. NO FURTHER INFO APPEARS TO BE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 095406 646309

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other